Durability and long-term clinical performance are critical considerations in individuals with severe mitral regurgitation (MR) who are not candidates for surgery or transcatheter repair. This analysis evaluated 5-year outcomes from a global pilot study of transapical TMVR in high-risk symptomatic MR.
Ninety-five individuals were enrolled (mean age 74.0 ± 9.2 years; 43.2% female; mean Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM] 6.5 ± 4.8%). Prior heart failure hospitalization occurred in 57.9%, and 88.4% presented with New York Heart Association (NYHA) Class III/IV symptoms. Secondary MR was present in 78.7%, and 76.6% had a left ventricular ejection fraction ≤50%.
Across 5 years, all-cause mortality reached 66.7%, and heart failure hospitalization occurred in 55.4%. One individual (1.1%) required mitral valve reintervention within 30 days. Hemodynamic valve deterioration was observed at 1.4%. Median mitral mean gradient remained stable at 3.6 mmHg (interquartile range 3.0-4.8). Residual MR was ≤ mild in all evaluated cases, and no paravalvular leak was observed. Functional improvement persisted, with 84.6% of survivors maintaining NYHA Class I/II.
These findings show sustained MR reduction and preserved valve performance in a group with complex cardiac disease. However, elevated long-term mortality emphasizes advanced baseline risk and the need for ongoing evaluation of transfemoral systems to improve access and outcomes.